Shire, Inc. gets FDA’s approval for the production and distribution of its latest long-acting ADHD drug Mydayis. This is the second license the FDA has released for the same industry in just two days.
Mydayis, the new gen of ADHD drug has been in research and development stage for a long time. Previously named SHP 465, the drug was then rejected by the FDA almost a decade ago. The drug has been side lined and postponed ever since.
The Dublin-based drugmaker decided to resume lobbying the drug’s approval and is now expected to hit drug stores by the third quarter of this year.
Mydayis contains the same active ingredients as Shire’s previous Adderall drug. It is said to have an extended release period thus affecting the user for a longer time than its predecessor.
It has been reported that Shire, Inc. predicts that the drug will become a $500 million product in just as little as three years; however, some critics and analysts doubt these projections.
Consensus puts the drugs revenues to reach only $288 million by that year, 2020. However, Shire’s analyst David Steinberg believes that skeptics will be proven wrong when that time comes.
The Mydayis drug has been approved by the FDA after being scrutinized under 16 clinical studies. According to Shire, 1,600 participants, both adults, and adolescents, volunteered for the experiments.
The med was measured using two scales of assessments. One assessment scale showed that the effects start to manifest after 2 to 4 hours of dosing and last up to 16 hours. The studies showed that the newly approved drug can improve the symptoms of ADHD.
“Many of my patients living with ADHD are trying to manage symptoms that impact them in different settings—often across home life, school or work, and in social settings,” said Andrew Cutler, a trial investigator in the clinical studies. “Patients have individual needs and may respond differently to treatments, so it is important for healthcare professionals to have multiple options.’
In comparison to Adderall XR, an older version of the ADHD drug, the effects of Mydayis lasted 16 hours, which is significantly longer than the former.
One of the challenges in marketing the drug is that generic versions of Adderall have come into the market. Many people are unaware of the difference between buying Mydayis and its generic counterpart; hence, some would choose the cheaper alternative.
According to Shire management they have high expectations on the sale of the drugs because they believe; “Shire’s market-leading salesforce and infrastructure [can] maximize Mydayis’ potential,” Steinberg noted. “Given Shire’s expertise in the area, we are inclined to agree with management, and note that every ADHD drug Shire launched has outperformed.”
Mydayis provides an alternative to its older counterpart, Adderall. Many controversies have hit the latter due to Adderall’s addictive properties, and a lawsuit Shire, Inc. had to pay for falsely marketing Adderall in the past. Some hope that the new drug can be a better drug for people with ADHD.